Sensory Testing and Brain Imaging for Menstrual Cramps
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on understanding menstrual cramps and their connection to other types of pain. Researchers use brain imaging (functional Magnetic Resonance Imaging, or fMRI) and sensory tests (Quantitative Sensory Testing) to examine how pain functions in the brain and body. The goal is to determine why some girls develop ongoing pain and how to prevent it. Girls aged 13-19 with regular periods who don’t use hormonal birth control might be suitable candidates for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance pain management for many.
Will I have to stop taking my current medications?
The trial requires that you have not used oral contraceptives, exogenous hormones, stimulants, or opioids in the previous 3 months. If you use other pain relievers, you will need to avoid taking them within 24 hours before a lab session.
What prior data suggests that these methods are safe for adolescent girls?
Research has shown that both fMRI and Quantitative Sensory Testing (QST) are generally safe for people. fMRI, a type of brain scan, has been widely used to study brain activity and structure in individuals with menstrual pain, with no major safety concerns reported.
Quantitative Sensory Testing measures how the body senses pain and temperature. It is non-invasive, meaning it doesn't involve cutting into the body. Studies indicate that participants tolerate QST well and find it safe.
Both methods have been used in numerous research studies without serious side effects, suggesting they are safe options for studying menstrual pain in clinical trials.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how brain imaging and sensory testing can deepen our understanding of menstrual cramps. Unlike typical treatments like NSAIDs or hormonal therapies that focus on alleviating symptoms, this approach aims to uncover the neurological and sensory pathways involved in pain. By using fMRI to visualize brain activity and quantitative sensory testing to assess pain response, scientists hope to gain insights that could lead to more targeted and effective treatments in the future.
What evidence suggests that this trial's methods could be effective for menstrual pain?
This trial will use functional MRI (fMRI) and Quantitative Sensory Testing (QST) to study menstrual cramps. Studies have shown that special brain scans, like fMRI, reveal important changes in the brains of people with menstrual pain. For instance, research indicates that girls with menstrual cramps exhibit different brain activity patterns compared to those without pain. This suggests that brain connectivity might influence how pain is felt and managed. QST measures sensations like touch or temperature, aiding in understanding pain sensitivity. While QST is helpful, it should not be the sole method for assessing pain sensitivity. Overall, understanding these brain and sensory patterns may lead to better ways to manage menstrual pain.13567
Who Is on the Research Team?
Laura Payne, PhD
Principal Investigator
Mclean Hospital
Are You a Good Fit for This Trial?
Adolescent girls aged 13-19 with regular menstrual cycles and period pain, who are right-handed, have a BMI of 35 or less, can read English, and have access to a smartphone or email. Parental consent is required for those under 18. Exclusions include severe mental health conditions, metal implants incompatible with MRI scans, chronic pain conditions like IBS, recent use of certain medications including stimulants and hormones.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo extensive phenotyping including pain inhibition testing and multimodal neuroimaging to obtain indices of brain structure and function
Monthly Pain Assessment
Menstrual pain severity and non-menstrual bodily pain are assessed monthly
12-Month Follow-up Assessment
Re-assessment of pain inhibition, brain structure, and connectivity to determine developmental trajectories
Follow-up
Participants are monitored for changes in menstrual and non-menstrual bodily pain
What Are the Treatments Tested in This Trial?
Interventions
- fMRI
- Quantitative Sensory Testing
Trial Overview
The study examines the brain's response to menstrual and non-menstrual pain in teens using sensory tests and fMRI scans. It aims to identify biomarkers predicting the development of persistent or chronic pain from primary dysmenorrhea (period pain without an organic cause) over two years.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
fMRI is already approved in United States, European Union for the following indications:
- Diagnostic imaging for various medical conditions, including neurological disorders such as mild TBI
- Diagnostic imaging for various medical conditions, including neurological disorders such as mild TBI
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mclean Hospital
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Quantitative sensory testing (QST). English version
Quantitative sensory testing (QST) is a standardized and formalized clinical sensitivity test. Testing describes a subjective (psychophysical) method that ...
Quantitative sensory testing | Neurology
QST is a potentially useful tool for measuring sensory impairment for clinical and research studies. However, QST results should not be the sole criteria used ...
3.
digital-assets.wellmark.com
digital-assets.wellmark.com/adobe/assets/urn:aaid:aem:8eeef038-1c63-4825-a87e-70afc8178759/original/as/quantitative-sensory-testing.pdfQuantitative Sensory Testing
Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. The existing evidence does not support the accuracy of current perception ...
Quantitative Sensory Testing Methods
Quantitative sensory testings (QSTs) are techniques employed to measure the intensity of stimuli needed to produce specific sensory perceptions.
Quantitative Sensory Testing (QST)
Quantitative sensory testing (QST) is a systematic psychophysical test method used to measure sensory thresholds for pain, touch, vibration, and temperature ...
6.
blueshieldca.com
blueshieldca.com/content/dam/bsca/en/provider/docs/medical-policies/Quantitative-Sensory-Testing.pdfQuantitative Sensory Testing
Quantitative sensory testing (QST) systems are used for the noninvasive assessment and quantification of sensory nerve function in individuals with symptoms ...
Quantitative sensory testing in a magnetic resonance ...
Quantitative sensory testing (QST) is often used to understand the perceptual basis of acute and chronic conditions, including pain.
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